We certainly are living in changing times and daily uncertainties, but my practice continues. Over the years, I have noted that when there is public angst, I have a bit freer time to review our outcomes. Alfred E. Neuman, the mascot for Mad Magazine during its heyday, had a motto “What, me worry?”; and I try to live by that motto. What I have learned from review of outcomes is that More Is Better; both in the quantity of biologics administered and the number of times repeated over a period of years.
Stem Cells Clinical Trial Update
By the end of July, we will have completed recruiting our Personalized Stem Cells Clinical Trial allotted number of patients. While the Adipose based Stem Cell Trial had started in the fall of 2019, all was put on hold until about a month ago owing to the Pandemic. Our initial observation is that there has been a significant decrease of symptoms and improved function in those who underwent liposuction and the knee intervention prior to the February temporary suspension of the Trial. The hope is that sometime this fall, the PSC Trial will allow recruitment of patients with significant symptoms and limitations generated by bilateral knee osteoarthritic involvement. At the same time, PSC will seek approval from the FDA for permission to expand the number of stem cells available for a patient by culturing.
Regenerative Medicine Update
While all this is taking place, please be reminded that our practice offers several options that have proven successful over time or with repeat procedures. First and foremost is the use of bone marrow derived stem cells, growth factors (cytokines), platelets and precursor cells in the arthritic joint. Many patients have returned both for a repeat intervention after some years or for attention to an additional symptomatic and function limiting joint. The patients, including myself, who have undergone several biologic injections be it proprietary, compounded, platelet rich plasma or the more recently available acellular amniotic fluid, have really benefited from the repeated series.
Last of all, I want to remind the reader that interested patients may access Adipose derived Stem cells outside of the PSC Clinical Trial if interested on a fee for service basis. The advantage of such is that several joints may be treated at the same sitting. In the latter scenario, a mini liposuction is completed and the recovered adipose tissue is prepared for immediate joint intervention via a methodology introduced by Lipogems. The end result of the Lipogems process is micronized adipose tissue; it has become quite popular in several biologic practices around the United States.
If you wish to explore these Regenerative and Orthobiologic options for an arthritic joint or joints, you may visit my web site and access my webinar at www.sheinkopmd.com. Even better would be to seek consultation in my office; you may schedule by calling (847) 390-7666.
Tags: orthobiologics, regenerative medicine, stem cell therapy
There are statistics and anecdotes that are used to review the outcomes of a particular cellular orthopedic treatment option and help determine what is best for a patient with arthritis. At times, it is difficult, and even impossible, to develop a sufficient number of patients with similar problems that might enable a statistical analysis. At that time, we have to base our recommendations on anecdotes; that is small numbers of patient responses. Two and a half years ago, a 67-year-old cycling enthusiast presented to our office with progressive pain and loss of motion owing to osteoarthritis of both knees. By the time he presented, the customary approaches to the arthritic knee had been exhausted including Physical Therapy, analgesics, non-steroidal anti-inflammatory medications, Hyaluronic Acid injections and arthroscopic “clean out.” Total Knee Replacements had been prescribed as the treatment option when all else had failed.
Patient Outcome Anecdotes
The patient had learned of my Cellular Orthopedic initiatives from his cycling group and sought consultation in our offices. The “team” of senior cyclists had experienced the recent loss of two team members because of their having experienced less than optimal outcomes following Total Knee Replacements. After our office assessment and review of images, I recommended a Bone Marrow Concentrate injection in both knees to help post postpone, perhaps avoid major surgery in the avid cyclist. I chose Bone Marrow Concentrate as the optimal means of delivering Adult Mesenchymal Stem Cells, Platelets, Precursor Cells and Growth Factor Proteins. The procedures were done on November 22nd of 2017. At this yearly follow up assessment, the patient reported that he has no pain, no limitation of function, requires no medications for arthritis and enjoys an unlimited weekly cycling routine approaching 300 miles per week.
A second example, or anecdote, is this senior athletic enthusiast, me. Many who know me are aware of my arthritic knees and hips for which I have had two rounds of biologic interventions in the past four years. Over the Memorial Day weekend, I cycled a combined 70 miles in Southwest Wisconsin, on hilly terrain, at times accompanied by my wife and twin grandsons; finished planting a large garden by hand; and helped clean our farmhouse, as we hosted and entertained our three grandchildren( ages 12, 10 and 10) with parents -the latter the most strenuous task of all.
While there is a medical cliché, “an anecdote does not a series make”, the vignettes above are real examples of what may be done for a symptomatic and functionally limiting arthritic joint. To learn more about orthobiologic options from proprietary Platelet Rich Plasma to stem cells and then some, call and schedule an appointment at (847) 390-7666. You may visit my website at www.sheinkopmd.com and watch my webinar.
Tags: arthritis pain, joint pain, patient outcomes, stem cell therapy, stem cell treatments
Every July 4th through Labor Day, from 1945 until 1954, my family would pack up the car and head off to spend the summer in Glenn, Michigan, several blocks from the lake. We lived in Humboldt Park on Division Street in Chicago. It was a third floor, one-bedroom apartment with a den. Air conditioning was not yet readily available. My brother and I shared the pull-out couch in the den. My father would drive out past the Gary Works Steel mills to Glenn each Friday night and return home on Sunday night so he wouldn’t miss work. He was a self-employed cabinet maker, having learned both his trade and the English language after fleeing Poland before WW2. He would take his yearly two-week vacation and spend it in the rented “cottage” ($50 for six weeks) equipped with an outhouse and a real ice box. The ice man came with a block twice a week. As there were no interstate highways or toll roads at the time, the drive would take 3 to 4 hours each way.
Social Distancing to Prevent the Spread of Illness
In medical school while studying infectious disease, I learned that the Summer 1952 Polio Epidemic had afflicted 57,628 Americans resulting in 3,145 deaths. It was only then when I realized the reason behind our yearly migration for Social Distancing. My family was avoiding the overcrowding that resulted in the spread of Polio, although, until Salk and Sabin, no one knew how. As an Orthopedic Surgeon at Children’s Memorial Hospital between 1974 to 1983, there were still several iron lungs in use to support children with respiratory distress, of varying causation, for prolonged periods. In the present COVID-19 Pandemic, the means of disease transfer is well understood. What remains to be done is the development of a treatment and a vaccination rendering immunity.
I share the following document from The Personalized Stem Cell group with whom I am an investigator for arthritis. I thought you would appreciate the government and White House briefings (two calls already with VP Task Force):
- We are manufacturing large quantities of allogeneic donor MSCs for treatment of COVID-19 patients
- Have approval of IRB for protocol
- Filing with FDA next week for emergency IND
- Attached draft of protocol justification manuscript
“Situation • The government has asked private biopharmaceutical companies to step up • Many Americans will die or have long term disability from COVID-19 • Critical we find treatments to keep people off ventilators and reduce mortality • PSC has 17 years of stem cell experience and has deployable resources to treat COVID-19 patients, but needs capital and fast track regulatory access
Why Stem Cell Therapy for COVID-19*
How patients die
- Massive inflammation by the body’s over-reaction to the viral invasion
- Lung inflammation prevents oxygen getting to the bloodstream
- Many patients will die even if a ventilator is available
Stem cell therapy – Scientific published evidence*
- Reduce lung damage and inflammation
- Improve oxygen supply to the body
- Repair damaged lung and prevent scar tissue
- Produce natural antibiotics and antivirals
- Clear edema and fluid from the lung
How Effective – Scientific Published Evidence*
- Reduce death loss by 50%-90%
- Reduce days in the ICU
- Reduce need for ventilator
- Clinical data that stem cells work against COVID-19 and other viral diseases
- Over 20 clinical studies started in China in just the last 60 days with early published striking results
How Safe – Scientific Published Evidence*
- Thousands of patients safely treated with stem cells in hundreds of clinical trials for a variety of diseases with very limited side effects
- Excellent published safety records
- Stem cells approved for many clinical uses in Europe, Canada, Korea, Japan, and Australia
*see accompanying manuscript on stem cells”
I will post the manuscript in my next blog post. To learn more, call (312) 475-1893. You may email about stem cells for COVID-19 at me at email@example.com.
Tags: coronavirus, COVID-19, how can stem cells be used for COVID-19, social distancing, stem cell therapy
I have been invited to participate in a Crain’s Chicago Business Orthopedic Roundtable discussion scheduled to appear in Crain’s on 02/24/2020. My focus will be on Orthobiologics and Cellular orthopedics. As readers of this blog are aware, I personally underwent orthobiologic interventions into my hips and knees in December. This past weekend, I trekked and trudged through 8 inches of snow to reach some of my favorite trout creeks in Southwest Wisconsin’s Driftless Area. While the fishing was slow to say the least and my fingers were frozen, my hips and knees did great.
Does Bone Marrow Concentrate really work?
From The Am J Sports Med. 2019 Oct;47(12):2881-2887. doi: 10.1177/0363546519867933. Epub 2019 Aug 21
Equivalent 10-Year Outcomes After Implantation of Autologous Bone Marrow-Derived Mesenchymal Stem Cells Versus Autologous Chondrocyte Implantation for Chondral Defects of the Knee.
The use of bone marrow-derived mesenchymal stem cells (BMSCs) in cartilage repair procedures circumvents some of the limitations of autologous chondrocyte implantation (ACI), but long-term outcomes for this newer procedure are lacking. The authors previously reported comparable outcomes for the 2 procedures at 2-year follow-up.
The purpose was to compare the long-term clinical outcomes of ACI versus BMSCs. It was hypothesized that there would be no significant difference between the groups in terms of patient-reported outcome scores and safety outcomes at 10-year follow-up.
Cohort study; Level of evidence, 2.
Seventy-two patients who underwent either ACI or BMSC implantation-matched in terms of age and lesion site- were followed up to a median of at least 10 years. Patients were assessed with the 36-item Short Form Health Survey (SF-36), the International Knee Documentation Committee knee evaluation form, the Lysholm Knee Score, and the Tegner Activity Scale. In addition, information was obtained regarding any additional surgical procedures as well as safety data, with particular attention to infection and tumor formation.
There was an improvement in all patient-reported outcomes scores apart from the Mental Component Summary of the SF-36 after cartilage repair surgery. There was no significant difference in any of the patient-reported outcomes between cohorts at any time point. Six and 5 patients in the ACI and BMSC groups, respectively, underwent subsequent surgical procedures, including 1 total knee replacement in the BMSC group. None of the patients in either group developed any deep infection or tumor within the follow-up period.
BMSC implantation used for the treatment of chondral defects of the knee appears to result in equivalent clinical outcomes to first-generation ACI at up to 10 years, with no apparent increased tumor formation risk.
An Update about our FDA-Approved Personalized Stem Cell Clinical Trial.
Some changes are taking place in the trial to allow an accelerated recruitment on the one hand; but an overall decrease in the number of subjects who will be allowed to participate. If you are interested, please call about changes in the inclusion criteria and costs: (312) 475 1893
Tags: Bone Marrow Concentrate, how does stem cell therapy work, stem cell therapy, what is bone marrow concentrate, what is regenerative medicine
The complexities inherent in biologics, cellular therapies, and stem cells as therapeutic entities are being been addressed at a number of levels. Thoughtful editorials, consensus statements, and even actions by state licensing boards, the FDA and the FTC for unprofessional conduct are starting to “drain the swamp.”
A large part of this growing industry consists of off-label uses; many in Regenerative Medicine seem to practice without FDA compliance. There are some indications where biologics and cellular therapies show genuine promise such as osteoarthritis, and my ongoing clinical research is conformational. Still owing to the bad actors, charlatans, and camp followers, substantive questions remain, including some basic concerns about safety, efficacy, cell sourcing and delivery, host response, and mechanism of action. There is only one way to approach this problem, and that is research with FDA governance (Personalizedstemcells.com).
In general, people thrive on novelty. We look for the latest and newest forms of treatment, hoping that the just-released remedy with the special formula will be the one to cure our problems and ease our pains. We do this as patients, and we do it as physicians. My major concern is that anyone licensed by the Department of Education and Registration may attend a weekend course, upload a web site, and begin fleecing an unsuspecting public.
Musculoskeletal disease and the resulting pain and loss of function are an invitation to the charlatans and camp followers: 20% of the population experiences arthritis and other serious musculoskeletal diseases. it’s not surprising that patients (and providers) will look anywhere for relief, and the bad actors will take advantage of an opportunity.
In the past, this approach has not worked well for many patients. The list of failed treatments for common musculoskeletal diseases is a long and sad one, from nutraceuticals to chelation therapy, and diets from alfalfa to zinc. At times, orthopaedic surgeons have not been careful stewards of clinical evidence—we continue to use viscosupplementation, despite the paucity of good evidence and we continue to use arthroscopic knee surgery in patients who should not have it. It would be nice, after all this, to get it right vis-à-vis stem cells and related treatments.
It appears that government sanctions, editorial sermons, and statements from specialty groups have not arrested the many dubious practice patterns we’ve all seen and too many patients experience. Witness the Amniotic Fluid debacle in Illinois last year perpetrated by the Bad Actors wherein patients were paying astonishing amounts of money (and taking yet-unquantified risk) for treatments that were of no benefit. The Amniotic Fluid marketed at seminars had and has no viable stem cells or biologics and cell therapies for regeneration of musculoskeletal tissues. The same holds true for Cord Blood and Wharton’s Jelly as evidenced by the epidemic of infections experienced in 2018 and 2019.
In this new decade, be informed, protect yourself, and seek out Board Certified Specialists in Regenerative Medicine if you want to postpone, perhaps avoid a joint replacement; or if you want to maintain or return to a fully active lifestyle. To schedule an appointment, call (312) 4745-1893. You may learn more at www.sheinkopmd.com.
Tags: biologics, cellular therapy, clinical trials, opinion on stem cell threeapy, stem cell therapy